RAD001(Everolimus) in Treating Patients With Myelodysplastic Syndromes
This study has been terminated.
(slow accrual)
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00809185
First received: December 16, 2008
Last updated: April 10, 2012
Last verified: April 2012
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Results First Received: January 20, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Myelodysplastic Syndromes |
| Interventions: |
Drug: everolimus Other: laboratory biomarker analysis Procedure: Bone marrow aspirate/biopsy |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Patients were recruited from Cleveland Clinic medical hospital from April 2006-March 2009 |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| RAD001(Everolimus) | drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period |
Participant Flow: Overall Study
| RAD001(Everolimus) | |
|---|---|
| STARTED | 7 |
| COMPLETED | 7 |
| NOT COMPLETED | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| RAD001(Everolimus) | drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period |
Baseline Measures
| RAD001(Everolimus) | |
|---|---|
|
Number of Participants
[units: participants] |
7 |
|
Age
[units: participants] Median ( Full Range ) |
67
( 60 to 81 ) |
|
Gender
[units: participants] |
|
| Female | 2 |
| Male | 5 |
Outcome Measures
| 1. Primary: | Number of Patients With Either a Major or Minor Erythroid Response(Hemoglobin Change From Baseline Measure) [ Time Frame: 2 years of treatment ] |
| 2. Secondary: | Dose- and Non-dose-limiting Toxicities [ Time Frame: at end of one cycle (28 days) ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
Yes
| 3. Secondary: | Laboratory Correlates (Cytotoxic T-cell Populations, S6K1 Levels, GSTT-1 Mutations, and Presence or Absence of HLA-DR15) [ Time Frame: at 2 years of treatment ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
| 4. Secondary: | Bone Marrow Morphology and Cytogenetics Pre- and Post-therapy [ Time Frame: at 2 years of treatment ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No
Serious Adverse Events Other Adverse Events
| Time Frame | Adverse events were measure during treatment which ranges from 5-196 days. |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 5% |
|---|
Reporting Groups
| Description | |
|---|---|
| RAD001(Everolimus) | drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period |
Other Adverse Events
| RAD001(Everolimus) | |
|---|---|
| Total, other (not including serious) adverse events | |
| # participants affected / at risk | 6/7 |
| Blood and lymphatic system disorders | |
| neutropenia † 1 | |
| # participants affected / at risk | 3/7 (42.86%) |
| thrombocytopenia † 1 | |
| # participants affected / at risk | 3/7 (42.86%) |
| General disorders | |
| bleeding † 1 | |
| # participants affected / at risk | 2/7 (28.57%) |
| fatigue † 1 | |
| # participants affected / at risk | 3/7 (42.86%) |
| weight loss † 1 | |
| # participants affected / at risk | 2/7 (28.57%) |
| Infections and infestations | |
| fever/infection † 1 | |
| # participants affected / at risk | 4/7 (57.14%) |
| stomatitis † 1 | |
| # participants affected / at risk | 2/7 (28.57%) |
| Renal and urinary disorders | |
| renal insufficiency † 1 | |
| # participants affected / at risk | 1/7 (14.29%) |
| Respiratory, thoracic and mediastinal disorders | |
| dyspnea † 1 | |
| # participants affected / at risk | 3/7 (42.86%) |
| pneumonitis † 1 | |
| # participants affected / at risk | 1/7 (14.29%) |
| Skin and subcutaneous tissue disorders | |
| rash † 1 | |
| # participants affected / at risk | 1/7 (14.29%) |
| † | Events were collected by systematic assessment |
|---|---|
| 1 | Term from vocabulary, CTCAE (2.0) |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| The trial was stopped early due to slow accrual. 18-33 patients were needed to address objectives, however only 7 patients were enrolled. Insufficient patients responded to the treatment to allow laboratory correlates with response to be analyzed. |
Results Point of Contact:
Name/Title: Anjali Advani
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
phone: 216-445-9354
e-mail: advania@ccf.org
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
phone: 216-445-9354
e-mail: advania@ccf.org
No publications provided
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00809185 History of Changes |
| Other Study ID Numbers: | CASE1905, P30CA043703, CASE-CCF-8514, CASE1905 |
| Study First Received: | December 16, 2008 |
| Results First Received: | January 20, 2012 |
| Last Updated: | April 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |